Drug Approval | June 25, 2025
Lupin receives USFDA approval for Prucalopride Tablets
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy
The company will provide the necessary response to USFDA within stipulated 15 days
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
his is the second license extension of a Nurix autoimmune disease program by Sanofi in the last 90 days
Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)
Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC) evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer
First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC
Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations
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